Laparoscopic Sleeve Gastrectomy Under General Anesthesia... | NCT04521543

Studies
Laparoscopic Sleeve Gastrectomy Under General Anesthesia in Severely Obese Patients: a Retrospective Study

NCT04521543

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Aug 20, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Oct 1, 2020Estimated

First Submitted Date

Aug 13, 2020

First Submission Date that Met QC Criteria

Aug 19, 2020

First Posted Date

Aug 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2020

Last Update Posted Date

Aug 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With the improvement of living standards and changes in living habits in China, obesity has become an important issue. The latest data show that the number of obese people in China has exceeded 100 million. Laparoscopic sleeve gastrectomy (LSG), which reduces the volume of the stomach and maintains the original anatomical structure of the gastrointestinal tract, has been widely used in weight loss surgery for obese patients to improve glucose metabolism and other metabolic disease comorbidities.Anesthesiologists face specific challenges for obese patients: difficult venous and airway access and the risk of obesity-related comorbidity.

Since 2015, the investigator's center has performed LSG and gradually formed a multidisciplinary collaboration procedure for the perioperative management of obese patients. This study aims to summarize the clinical characteristics, anesthesia management and outcomes to optimize the perioperative management and accelerate the recovery of these patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of one-time intubation success	the intubation was performed once successfully	during the anesthesia

Secondary Outcomes

Measure	Description	Time Frame
number of participants with anesthesia-related complications	such as difficult ventilation, difficult intubation, or hoarseness.	Perioperative period
the hospital stay (days)	total time of hospital stay (days)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients aged>18 years
American Society of Anesthesiologists (ASA) status I-III
receiving selective laparoscopic sleeve gastrectomy (LSG) under general anesthesia

Exclusion Criteria:

1.BMI<35 kg/m2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Severely obese patients underwent laparoscopic sleeve gastrectomy (LSG) under general anesthesia with multidisciplinary collaboration.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shengjin Ge, Ph.D.	Contact	021-64041990		ge.shengjin@zs-hospital.sh.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital Fudan University	Recruiting	Shanghai	Shanghai Municipality	200032	China

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided